Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

FDA's 483 Playbook: What It Means For Pharma Outsourcing — And What It Doesn't Address

For those involved in outsourcing, the new FDA draft guidance regarding FDA Form 483 observations reshapes the accountability framework. The public comment period ends May 8.

GUEST COLUMNISTS

SUS Interchangeability Assessment And Qualification Best Practices
Establishing a robust single-use systems (SUS) interchangeability program can be a pivotal feature of a supply chain resiliency initiative.
Delivery Strategy For Next-Gen Cardiac Gene Therapies
As the field matures, the most transformative gene therapies in heart health are treating delivery not as an afterthought but as a fundamental principle.
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Accelerating Technology Diffusion In Cell And Gene Therapy
Unlike most other drugs, advanced therapies require complex, purpose-built supply chain networks. Making them requires cross-sector collaboration.
5 QMS Blind Spots You Should Know About
Companies often underestimate the complexity of standing up an eQMS. These are five of the most common issues that lead to regulatory and GMP exposure risk.
Outsourcing? When Both Sides Of The Table Are Investor-Backed, Everything Changes
The outsourcing relationship is increasingly not sponsor versus provider. It is two investor-backed organizations navigating parallel pressures — with a shared program sitting in the middle.
Dynamic Flux Analysis Offers Faster Metabolic Modeling Than DOE
By continuously analyzing spent media, researchers can estimate reaction rates at regular time points, providing a granular view of cell metabolism.
Green Supply Chains Rarely Start With A Pledge; Target Waste Instead
Effective sustainability strategies in pharma supply chains reduce rework and overage. Three leakage points offer the most practical starting point for rooting out waste.
The Real Reason We Haven't Fully Automated Cell Therapy Yet
Manual cell therapy workflows often set the tone for automation. This discussion suggests the approach is flawed and presents automation as a chance to innovate.

PHARMA OUTSOURCING WHITE PAPERS

Patented Process For Intermediates Useful For Etrasimod Arginine
Explore how rethinking the synthetic strategy for Etrasimod can overcome the limitations of legacy routes, enabling more efficient chirality control, improved scalability, and more practical industrial API production.

Performance Characteristics Of The Mobius® ADC Reactor For Conjugation
Explore results from a series of studies evaluating the mixing performance of an innovative ADC reactor during the conjugation step utilizing a model fluid.
AAV-Based Gene Editing For Huntington's Disease
LETI-101 uses AAV5 to deliver a compact CRISPR system for allele-selective editing of mutant HTT, showing promise as a one-time treatment for Huntington’s disease with strong preclinical safety and efficacy.
Revolutionizing Drug Discovery From "Undruggables" To AI
Explore four current trends in drug discovery, how each trend addresses some of the most crucial challenges in drug discovery, and the obstacles to their widespread adoption.
Is Mannitol Hemihydrate Detrimental To Protein Stability?
Maintaining an amorphous excipient matrix is crucial for protein stability. Learn about the importance of storage conditions in managing mannitol hemihydrate dehydration and ensuring protein stability.
Revolutionizing Lentiviral Vector Manufacturing For In Vivo, Ex Vivo CAR-T Therapies
Discover how scalable, cost-effective, and high-quality lentiviral vector manufacturing can accelerate both ex vivo and emerging in vivo CAR-T therapies.